FDA Medical Device Recalls (openFDA)
Argo Medical Technologies Ltd: ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.
- Recall number
- Z-1553-2021
- Recalling firm
- Argo Medical Technologies Ltd
- Product
- ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.
- Status
- Terminated
- Initiated
- 2020-02-28
- Posted
- not on file
- Terminated
- 2021-11-10
- Reason
- ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged.
- Root cause
- Device Design
- Action
- Rewalk issued Customer Communication Letter - Proper Operation and Storage of the ReWalk System Batteries to ReWalk System Owners, Companions, Distributors and ReWalk Certified Physiotherapists via certified Mail on 2/28/20. Letter states reason for recall, health risk and action to take: " General: o Do not charge the batteries while wearing the device. o If the battery usage time becomes much shorter than usual, contact your ReWalk representative. o Do not store, charge or use the system in an environment where the ambient temperatures may be higher than 113 Fahrenheit (45 Celsius) or lower than 32 Fahrenheit (0 Celsius). o Improper handling of the ReWalk Main and Aux rechargeable batteries may cause chemical leakage, heat, smoke, fire, or an explosion. " During System Charging: o When connecting the charger to the system, make sure the connector is securely screwed in place. o Do not charge the batteries continuously for more than 8 hours. If the battery is not fully charged after 8 hours - discontinue charging, stop the usage of the system and call your ReWalk Service representative. o Make sure to fully charge the system after each use. o The system is fully charged when the charger LEDs are Green. o Do not charge the system if the charger LEDs are flashing - discontinue charging, stop the usage of the system and call your ReWalk Service representative. " Charging Before System Storage: o Short term storage (7 days or less) The system must be fully charged before storage. The ReWalk system should be fully charged at least once a week. o Long term storage (more than 7 days) Fully charge the system before storage, then turn off the system, open the waistpack and disconnect the Main and Aux battery plugs (refer to the relevant steps in the User Guide). For first use after storage connect the plugs, close the waistpack and charge the system until the charger LEDs are Green. Do not charge the batteries for more than 8 hours
- Quantity
- 350 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All Serial numbers
- 510(k) numbers
- ["K160987","K200032"]
- PMA numbers
- not on file
- Product code
- PHL
- Firm FEI
- 3007615665
- Firm city
- Haifahaifa
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28